A SHORT-TERM, MULTICENTER, RANDOMIZED DOUBLE-BLIND DOSE TITRATION STUDY OF THE EFFICACY AND ANTICHOLINERGIC SIDE EFFECTS OF TRANSDERMAL COMPARED TO IMMEDIATE RELEASE ORAL OXYBUTYNIN TREATMENT OF PATIENTS WITH URGE URINARY INCONTINENCE

Abstract Context It has been suggested that stimulation of lipolysis by diazoxide (DZX)-mediated insulin suppression may be useful in treating obesity. However, the optimal dose to promote lipolysis without causing hyperglycemia is unknown. Objective To assess the effects of DZX in nondiabetic obese men on lipid and glucose metabolism. Design Double-blind, placebo (PL)-controlled, 6-month trial in men with a body mass index of 30 to 37.5 kg/m2 treated with a combination of caloric restriction, a standardized exercise program, and DZX or PL dose escalation. Results The mean maximal tolerated dose of DZX was 422 ± 44 mg/d (range, 200 to 700 mg/d). Dose-limiting events were edema (n = 11), hyperglycemia (n = 6), and nausea (n = 2). After dose reduction to a level free of clinical side effects, DZX treatment was associated with a markedly greater decrease in fasting insulin levels than PL (−72.3 ± 3.5% vs −23.0 ± 12.6%; P < 0.001) and a significant improvement of blood pressure and plasma lipid levels. The decline in insulin levels occurred at the cost of a small increase in plasma glucose (0.6 ± 0.2 mmol/L vs −0.1 ± 0.1 mmol/L; P = 0.04) and hemoglobin A1C (0.2 ± 0.1% vs 0.0 ± 0.1%; P = 0.17). Conclusion In nondiabetic obese men, insulin levels can be reduced up to 70% without major metabolic side effects. The marked intersubject variation in maximal tolerated dose indicates that DZX dose titration needs to be individualized.

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Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Preschool Children with Attention-Deficit/Hyperactivity Disorder

Journal of Child and Adolescent Psychopharmacology ◽

10.1089/cap.2019.0085 ◽

2020 ◽

Vol 30 (2) ◽

pp. 58-68

Author(s):

Ann C. Childress ◽

Scott H. Kollins ◽

Henry C. Foehl ◽

Jeffrey H. Newcorn ◽

Greg Mattingly ◽

...

Keyword(s):

Attention Deficit Hyperactivity Disorder ◽

Preschool Children ◽

Attention Deficit ◽

Extended Release ◽

Dose Titration ◽

Double Blind ◽

Double Blind Placebo ◽

Hyperactivity Disorder ◽

Flexible Dose ◽

Titration Study

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A double-blind randomized study of fetal side effects during and after the short-term maternal administration of indomethacin, sulindac, and nimesulide for the treatment of preterm labor

American Journal of Obstetrics and Gynecology ◽

10.1067/mob.2003.255 ◽

2003 ◽

Vol 188 (4) ◽

pp. 1046-1051 ◽

Cited By ~ 57

Author(s):

Robert J. Sawdy ◽

Shiromi Lye ◽

Nicholas M. Fisk ◽

Phillip R. Bennett

Keyword(s):

Side Effects ◽

Preterm Labor ◽

Randomized Study ◽

Short Term ◽

Double Blind ◽

Maternal Administration

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A randomized, double-blind, double-dummy, crossover trial comparing the safety and efficacy of oral sustained-release hydromorphone with immediate-release hydromorphone in patients with cancer pain. Canadian Palliative Care Clinical Trials Group.

Journal of Clinical Oncology ◽

10.1200/jco.1996.14.5.1713 ◽

1996 ◽

Vol 14 (5) ◽

pp. 1713-1717 ◽

Cited By ~ 48

Author(s):

E Bruera ◽

P Sloan ◽

B Mount ◽

J Scott ◽

M Suarez-Almazor

Keyword(s):

Palliative Care ◽

Side Effects ◽

Cancer Pain ◽

Pain Intensity ◽

Opioid Analgesic ◽

Immediate Release ◽

Ordinal Scale ◽

Global Rating ◽

Double Blind ◽

Safety And Efficacy

PURPOSE To evaluate the safety and efficacy of a new slow-release preparation of hydromorphone (SRH) in the treatment of cancer pain. PATIENTS AND METHODS Ninety-five adult patients from three Canadian Palliative Care Centers with no evidence of mental impairment received treatment for cancer pain with an oral opioid analgesic. After informed consent was obtained, patients underwent titration to a stable dose of immediate-release hydromorphone (IRH) for 48 hours, and were then randomized to receive IRH or SRH for 5 days in a double-blind basis. During day 6, a crossover took place, and patients received the alternate drug for 5 days. Pain intensity was assessed using a visual analog scale (VAS) and ordinal scale (OS). Side effects were assessed using VAS. Patients and investigators made a blinded global rating of efficacy a blinded final choice between SRH and IRH. RESULTS In 75 assessable patients, pain intensity of the VAS and OS were (mean +/- SD) 27 +/- 21 and 1.3 +/- 0.6 on IRH, versus 29 +/- 21 (P = .13) and 1.3 +/- 0.6 (P = .19) on SRH, respectively. The total number of extra doses of opioids, global rating, and final blinded choice by both patients and investigators were not significantly different between IRH and SRH. Differences in side effects were not significant. CONCLUSION Our findings suggest that SRH is as safe and effective as IRH in the treatment of cancer pain.

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Ranitidine in the Treatment of Duodenal and Prepyloric Ulcer: Comparison of Two Dosage Regimens

Journal of International Medical Research ◽

10.1177/030006058301100307 ◽

1983 ◽

Vol 11 (3) ◽

pp. 167-172 ◽

Cited By ~ 4

Author(s):

H Brunner ◽

F X Pesendorfer ◽

R Pötzi

Keyword(s):

Side Effects ◽

Mucosal Inflammation ◽

Controlled Study ◽

Short Term ◽

Double Blind ◽

Laboratory Findings ◽

Dosage Regimens ◽

Prepyloric Ulcer ◽

Daily Dose

In a double-blind controlled study eighty-two patients with duodenal or prepyloric ulcer were treated with either 100 mg or 150 mg ranitidine twice daily. After 4 weeks of treatment the ulcer had healed in twenty-two of forty-one patients (54%) on 200 mg of ranitidine and in thirty-six of forty-one patients (88%) on 300 mg of ranitidine. In the x2-test this difference was statistically significant (p < 0·01). Relief of pain and reduction of mucosal inflammation were similar in both groups. There were no drug-related side-effects nor consistent changes in laboratory findings. We conclude that a daily dose of 300 mg ranitidine is superior to 200 mg ranitidine in the treatment of duodenal and prepyloric ulcer and that the short-term use of ranitidine seems to be safe for the treatment of these ulcers.

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